Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain

NCT ID: NCT01450345

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-12-31

Brief Summary

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The study carry out is to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in post-operative pain management.

Detailed Description

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Conditions

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Inguinal Hernia Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Pregabalin Group

The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.

Interventions

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Pregabalin

The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.

Intervention Type DRUG

Other Intervention Names

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Lyrica 150mg

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of inguinal hernia
* Patient undergo operation under daycare basis
* ASA I-II
* Written consent

Exclusion Criteria

* ASA \> II
* Allergic reaction against gabapentin and/or pregabalin
* History of recurrent hernia repair.
* Patient who has taken analgesia prior to the surgery
* Liver failure
* Renal failure
* Pregnancy
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Toh Charng Chee

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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CharngChee Toh, MBBS, MRCS

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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University Malaya

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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CharngChee Toh, MBBS, MRCS

Role: CONTACT

60193380337

Facility Contacts

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CharngChee Toh, MBBS, MRCS

Role: primary

60193380337

Other Identifiers

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toh2c79@Pregabalin

Identifier Type: -

Identifier Source: org_study_id